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GF Health Products, Inc

United States·US-MF-000002167

Last updated September 17, 2026

Information

Country: United States
Address: One Graham Field Way, Atlanta, United States
Website: www.grahamfield.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +17703684700
PRRC Contact: Amy Piccini
EUDAMED SRN: US-MF-000002167
FDA FEI Number: 2427360
DUNS Number: —

Catalogue (4538)

Page 12 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	460-FS-PS-NA	FDA UDI	Class I	Active
Grafco	3953 1	FDA UDI	Class I	Active
Intensa	620-DA-OG	FDA UDI	Class I	Active
Intensa	IN601UHBT	FDA UDI	Class I	Active
Intensa	460-AA-PS-T5	FDA UDI	Class I	Active
Intensa	744CB-VI	FDA UDI	Class I	Active
Hausted	6200-ST	FDA UDI	Class I	Active
Lumex	LCM3580RB	FDA UDI	Class II	Active
Intensa	IN597P9207	FDA UDI	Class I	Active
Intensa	IN577RGPL	FDA UDI	Class I	Active
Grafco	1806	FDA UDI	Class I	Active
Intensa	744-BL-BCSW	FDA UDI	Class I	Active
Grafco	1197#4	FDA UDI	Class I	Active
Intensa	460-AA-PS-PL	FDA UDI	Class I	Active
Intensa	420-EO-MO	FDA UDI	Class I	Active
Hausted	4600-FL-DO	FDA UDI	Class I	Active
Lumex	FR587W9201PA	FDA UDI	Class I	Active
Intensa	IN587WD1315PA	FDA UDI	Class I	Active
Intensa	460-FS-T6	FDA UDI	Class I	Active
Hausted	4200-EO-PL	FDA UDI	Class I	Active
Intensa	IN566DGH8567PA	FDA UDI	Class I	Active
Lumex	FR566GH8602	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-PM	FDA UDI	Class I	Active
Hausted	4600-FS-PS-MO	FDA UDI	Class I	Active
Transfer Master	B407-T84-C	FDA UDI	Class II	Active
Intensa	IN577RGH427	FDA UDI	Class I	Active
Intensa	IN601PHBL	FDA UDI	Class I	Active
Intensa	IN587WDDOPA	FDA UDI	Class I	Active
Intensa	IN566DG9205PA	FDA UDI	Class I	Active
Hausted	4600-PS-NO	FDA UDI	Class I	Active
Gendron	7150P183	FDA UDI	Class I	Active
Lumex	2195A-4	FDA UDI	Class I	Active
Hausted	4600-FS-PS-GR	FDA UDI	Class I	Active
Lumiscope	100-510	FDA UDI	Class II	Active
Lumex	FR566DGH8808	FDA UDI	Class I	Unknown
Hausted	4600-AA-DB	FDA UDI	Class I	Active
Grafco	2633	FDA UDI	Class I	Active
Intensa	IN587WHTEPA	FDA UDI	Class I	Active
Intensa	IN587WH432	FDA UDI	Class I	Active
Lumex	FR566DGH6714PA	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-DB	FDA UDI	Class I	Active
Intensa	620-WG	FDA UDI	Class I	Active
Intensa	IN597G6724	FDA UDI	Class I	Active
Lumex	FR587WDH454	FDA UDI	Class I	Active
Basic American Medical Products	ZZA99174	FDA UDI	Class II	Active
Lumex	FR597G8602	FDA UDI	Class I	Active
Intensa	460-AA-DB	FDA UDI	Class I	Active
Hausted	4200-EO-MO	FDA UDI	Class I	Active
Intensa	IN587WH409PA	FDA UDI	Class I	Active
Lumex	FR566DG1311PA	FDA UDI	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 24, 2021	Z-1353-2021	—	terminated	The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
Sep 30, 2016	Z-0732-2017	—	terminated	GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.
Sep 14, 2009	Z-0139-2010	—	terminated	Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.